The US FDA allows propofol to be mixed in separate packages to meet demand

The US Food and Drug Administration (FDA) said that after allowing pharmacists and outsourced sites to re-equip 13 medicines used to treat patients using ventilators during the new crown epidemic, it will also allow pharmacists to split or re-compound Propofol meets the needs of the hospital.



Due to increasing demand for medicines or supply chain problems, five manufacturers have reported that there is a shortage of many types of propofol.



The US FDA wrote: "Several hospitals report to us that they have difficulty obtaining our approved 10 mg / ml propofol emulsion injection to support new crown patients who have received sedation and intubation treatment or Other operations that care for these patients. "Specifically, the bureau stated that it is expanding the application of the discretionary policy set forth in the dispensing guidelines, allowing pharmacists to dispense or reconstitute the 10 mg / ml C approved by the bureau. Propofol products.



The FDA explained that the new guidelines were issued to address some issues that "exceeded" its packaging guidelines. According to the original packaging guidelines, the FDA requires packaging drugs "to be packaged, stored, and transported in a manner that does not conflict with their approved labels." Due to the approved label declaration of propofol, this drug "will oxidize and degrade in an aerobic environment, so it needs to be packaged under a nitrogen environment to eliminate this degradation method," the FDA said. This medicine will be contrary to the regulations in the packaging guide. However, since outsourcing sites and pharmacies may not have the ability to dispense under nitrogen, the bureau stated that they are allowed to fail to comply with this requirement in emergency situations.



Another problem solved by the new policy is how to formulate different propofol preparations. The US FDA stated that compounding different propofol formulations "may lead to a reduction in the antibacterial and antiseptic effect of the finished product." Therefore, based on whether propofol products contain matching preservatives or antioxidants, FDA has added different requirements for compounding such products. Similarly, the new guideline also sets out parameters related to containers, tubes and expiration date for the dispensing or compounding of propofol.